Edwards Lifesciences

This study aims to see if a less invasive procedure to replace a narrowed heart valve is as safe and effective as traditional open-heart surgery for patients who are at low risk for surgery. About 1,000 patients with severe aortic stenosis will be randomly assigned to receive eit…

This study is testing a device called the Cardioband FIT System to repair leaky tricuspid heart valves. Doctors will use a catheter (a thin tube) to place the device in the heart without major open-heart surgery. The goal is to see if this approach is safe and can help reduce the…

This study is tracking the long-term safety and performance of a specific replacement aortic heart valve in Chinese patients. It will follow up to 250 adults who receive the valve for up to 10 years after their surgery. The main goal is to see how well the valve works over time a…

This study is collecting real-world information on how well a new replacement mitral heart valve works and how safe it is for patients. It will follow about 500 adults who need their leaky or narrowed mitral valve replaced. The main goals are to see if the valve lasts without cau…

This study aims to monitor the safety of a second, less invasive heart valve procedure for people whose first artificial aortic valve is not working properly. It will follow 50 adults for one month after they receive a new valve inside their old one, tracking serious complication…

This early study is testing a new device called the Edwards APTURE Transcatheter Shunt System. It is designed to be implanted in the heart to help relieve pressure for people with symptomatic heart failure. The main goal is to see if the device is safe and works as intended in th…

This study is testing a new two-part device designed to fix leaky or narrowed pulmonary heart valves in people born with certain heart defects. The device is implanted using a catheter through blood vessels, avoiding open-heart surgery. Researchers want to see if it's safe and ef…

This study is monitoring the safety and performance of a recently approved heart valve device for people born with specific heart defects. It involves 150 participants who need a new pulmonary valve. The goal is to see how well the device works in real-world use after it received…

This trial is testing a new device called the Edwards EVOQUE system, which is implanted via a catheter to replace a leaky tricuspid heart valve. It aims to see if this implant, along with standard medication, is safer and more effective than medication alone for patients with sev…

This study is testing a catheter-based procedure to replace failing artificial mitral heart valves. It involves 53 patients who have symptoms like shortness of breath due to their old valve not working properly. Doctors are checking if this less invasive approach is safe and help…

This study is monitoring the safety and performance of a specific replacement heart valve (the SAPIEN 3) in people born with complex heart defects. It focuses on patients whose existing pulmonary valve is failing, causing blood to leak back or creating a blockage. The goal is to …

This study is checking if changes to how replacement heart valves are made and packaged are safe and work well. It involves 777 adults who need to replace a damaged aortic or mitral valve. Researchers will follow participants for up to 5 years to see how the valves hold up and if…

This trial is testing a small, implanted device called the APTURE shunt to see if it helps people with certain types of heart failure who still feel poorly despite taking the best available medications. About 100 participants will be randomly assigned to receive either the real s…

This study is testing a new, minimally invasive device called the APTURE shunt in people with heart failure. The device is implanted to create a small opening between heart chambers, aiming to safely reduce high blood pressure in the lungs and heart. Researchers will check if the…

This study is testing a new device called the EVOQUE system, which is designed to replace a leaky tricuspid heart valve using a catheter inserted through a blood vessel, avoiding open-heart surgery. The trial aims to see if this procedure is safe and effective at reducing severe …

This large study is comparing two different devices that repair a leaky mitral heart valve without open-heart surgery. It involves over 1,200 patients who are at high risk for surgery or have heart failure. The main goal is to see if the newer PASCAL device is as safe and effecti…

This study is testing the safety and performance of a new, less invasive heart valve replacement system. It is for people with severe, symptomatic aortic stenosis who are at intermediate risk for traditional open-heart surgery. The goal is to see if this new device can effectivel…